PREGNANCY-SKREEN Liquid Urine Controls, Positive, 5ml

Quick Overview

Details

The Pregnancy-Skreen product line of controls is manufactured using a human based urine matrix that has been stabilized to insure that the product will be viable until the date of expiration. The positive control is spiked with hCG in a target range from 200-400 mIU/mL of urine matrix. The negative control is prepared from a urine pool that tested negative for hCG. The standard material used for spiking was obtained from human pregnancy urine lyophilized and found negative by ELISA to HIV-1, antibody for HCV and for HBSAG. The initial assay of the lyophilized material used for spiking was performed by radioimmunoassay. Subsequent testing of the control material is performed qualitatively to ascertain that positive controls tested positive and the negative controls tested negative for the claimed life of the product.

Each bottle contains stabilized human based urine in a convenient liquid form. Positive control urines have been spiked with known quantities of purified Human Chorionic Gonadotropin (hCG). Negative control urine is certified negative for the constituents listed in this insert.

STORAGE & STABILITY

Unopened:

The controls are stable until the expiration date when stored refrigerated at (2-8C). When stored at room temperature (18-25C) the controls are stable for 31 days or until the expiration date, whichever comes first.

This product should never be stored frozen.

After Opening:

The controls are stable for 31 days or until the expiration date, whichever comes first, when stored refrigerated (2-8C) or at room temperature (18-25C).

PROCEDURE

Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.

Pipette an appropriate aliquot of Pregnancy-Skreen control urine as required by the hCG immunochromatographic device or screening method.

This product is not meant to be used as a standard or calibrator.

Expected Results

The positive Pregnancy-Skreen control must test positive and the negative Pregnancy-Skreen control must test negative.

LIMITATIONS OF PROCEDURE

This control is meant to be used to validate the performance of qualitative urine hCG methods that screen urine for hCG levels consistent with pregnancy.

Consult test manufacturers instructions when using this product; changes in reagents, sample requirement, or methodology may effect test results.